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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR COHESIVE GEL BREAST IMPLANTS

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MENTOR COHESIVE GEL BREAST IMPLANTS Back to Search Results
Model Number 350-5455BC
Event Type  No Answer Provided  
Event Description

I have mentor cohesive gel breast implants and experienced symptoms almost immediately. They continue to get worse. I have been diagnosed with sjogrens, myalgia, low c4 and anemia. Rheumatologist said i am at high risk for lymphoma. I have chronic widespread pain and digestive trouble. Severe food, drink and chemical sensitivity. I was healthy and active prior to breast implants.

 
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Brand NameCOHESIVE GEL BREAST IMPLANTS
Type of DeviceCOHESIVE GEL BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6537228
Report NumberMW5069470
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received04/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-5455BC
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/28/2017 Patient Sequence Number: 1
Treatment
CBD OIL
IRON.
OTC MEDS: PROBIOTICS
RX MEDS: CBD OIL 250 MLG PER DAY.
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